Teva Pharmaceuticals USA recalls Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-1
Recalled February 22, 2017 · FDA recall D-0479-2017 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. · FDA Class II
Units
17,473 cartons
Sold at
Nationwide in the United States
Description
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Product
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →